RE:RE:RE:RE:RE:Positive thoughts Hey Donlin,
I think you posted this question few times before....
and from what I remember, that FDA submission was on behalf of the previous company who owned the Scout.... and they didnt submit/classify/file the device correctly.
Miraculins officially took over in late 2013
In 2014 they had to retract the submission and figure out the proper path from what I underrstood in the MD&A or some rticle/interview of theirs.
Beginning of 2015, they announced their roadmap.
Hence why Mirculins today goes out their way or makes a point of stating the type of submission (educating the shareholders). Stating the type of classification it is supposed to be under, the differences of class types, etc....
Donlin wrote: If memory serves me correctly the SCOUT went into its USFD cycle in Dec 2013 with its pre-submission documentation. Almost two years ago. And this is for a non-invasive device. I can understand with the "actual in the body" drugs but really...... I don't get it!!!! What is MOM not telling us.